TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose Meter (REF REA4007-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00050428354766), received between Feb 6, 2017 and Dec 18, 2018 — classified as 24 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2018Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR BATTERY ISSUE/LOW BATTERY SYMBOL. THE LOW BATTERY SYMBOL APPEARED ONCE THE TEST STRIP WAS INSERTED INTO THE TRUEMETRIX AIR METER AND WHEN THE "DOT" BUTTON WAS MANUALLY PRESSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING A HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE CUSTOMER WAS USING THE PROPER TEST STRIPS AND THE BATTERY HAD BEEN INSTALLED PROPERLY. THE BATTERY HAD NOT BEEN REPLACED.

  Patient problems: Headache

  MAUDE report 8173831 ↗
• MalfunctionOct 23, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 200 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE TIME OF THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995108 ↗
• MalfunctionAug 23, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-2 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER'S MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER AND DID REPORT SYMPTOM OF FEELING SHAKY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER USING THE TRUE METRIX AIR AND PRODUCED TEST RESULT OF E-2. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE IS IN THE MONTH OF (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Shaking/Tremors

  MAUDE report 7811042 ↗
• MalfunctionJul 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 307, 467, 338 AND 353 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/15/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658998 ↗
• MalfunctionMay 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ERROR CODE ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE RESULT RANGE WAS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE. MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE E-0 APPEARS WHEN THE BLOOD SAMPLE IS ABSORBED. THE CUSTOMER IS HAVING A HEADACHE ANS SAYS IT HAPPENS WHEN THE SUGAR IS UP AND CUSTOMER DENIES THE NEED OF MEDICAL ATTENTION. CUSTOMER STATES OVERALL HEALTH IS POOR. THE CUSTOMER HAS KIDNEY FAILURE. CUSTOMER WAS ADVISE TO SPEAK TO THE DOCTOR AND CUSTOMER HANG UP THE CALL.

  Patient problems: Headache

  MAUDE report 7518491 ↗
• MalfunctionApr 10, 2018Low Test Results; Low Test Results

  CUSTOMER CALLED IN FOR CONTROL SOLUTION AND VERIFIED THAT CUSTOMER IS USING EXPIRED TEST STRIPS. CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON OF 420 MG/DL USING THE HOSPITAL'S METER VS 320 MG/DL USING THE TRUE METRIX AIR METER. CUSTOMER HAD LAB WORK DONE AND HER RESULTS SHOWED SHE WAS IN FACT 420 MG/DL FASTING. CUSTOMER WAS USING EXPIRED TEST STRIPS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING HYPERGLYCEMIC. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2017 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1: 320 MG/DL FASTING ( TRUE METRIX AIR). PRIOR TO CALL CUSTOMER WAS FEELING HYPERGLYCEMIC, STATES HER INSULIN STOPPED WORKING. SHE WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH HYPERGLYCEMIA (420 MG/DL USING HOSPITAL METER). SH

  Patient problems: Hyperglycemia

  MAUDE report 7411564 ↗
• MalfunctionMar 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF E-5. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF EXCESSIVE THIRST AND FATIGUE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER IS EXPERIENCING HYPERGLYCEMIC SYMPTOMS INCREASED THIRST AND FATIGUED. CUSTOMER UNABLE TO ANSWER ANY FURTHER QUESTIONS DUE TO SYMPTOMS.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 7318747 ↗
• MalfunctionMar 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. SON IN LAW IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS SIX MONTHS AGO (EXPIRED OPEN DATE MORE THAN 4 MONTHS). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1:308MG/DL DATE: (B)(6) 2018 TIME:1042AM FASTING, RESULT 2:237MG/DL DATE: (B)(6) 2018 TIME:10:42AM FASTING, RESULT 3:157MG/DL DATE: (B)(6) 2018 TIME:10:48AM FASTING, RESULT 4:139MG/DL DATE: (B)(6) 2018 TIME:10:47AM FASTING, RESULT 5:182MG/DL DATE: (B)(6) 2018 TIME:12:38PM FASTING. CUSTOMER CALLING STATES THAT THEY WOULD GIVE DIFFERENT RESULTS EVERY TIME THEY RUN A BLOOD TEST. CUSTOMER HAVE NOT USE THE METER FOR A WHILE NOW. CUSTOMER GOT THE METER AND STRIPS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317348 ↗
• MalfunctionNov 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED WHEN THE TEST STRIP WAS INSERTED. THE CUSTOMER WAS NOT TESTING WITH A USED TEST STRIP. THE TEST STRIP VIAL WAS NOT LEFT OPEN AND TEST STRIPS WERE NOT REMOVED FROM THE ORIGINAL CONTAINER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER WAS NOT FEELING WELL AND HAD DIABETIC SYMPTOMS; THE CUSTOMER DID NOT PROVIDE DETAILS ON WHAT THE SYMPTOMS WERE. THE CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Information

  MAUDE report 7037029 ↗
• MalfunctionAug 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 TO 115MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF (B)(6) USING METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS 8/5/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6829818 ↗
• MalfunctionAug 15, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 182, 202 AND 264 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 80 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/16/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER TAKES HER BLOOD TEST FASTING. SHE ONLY USED THE METER 3 TIMES AND SHE IS NOT USING IT ANYMORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6794439 ↗
• MalfunctionAug 7, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 302, 347 AND 508 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/19/2018 AND OPEN VIAL DATE IS JUNE 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET; MEMORY CONCERNS: 302, 347, 508, 523, 545 MG/DL): 1:3 47MG/DL N/A 12:00 PM FASTING:YES. 2: 302MG/DL N/A 12:00 PM FASTING:YES. 3: 508MG/DL N/A 12:00 PM FASTING:YES. 4: 545MG/DL N/A 12:00 PM FASTING:YES. 5:5 23MG/DL N/A 12:00 PM FASTING:YES. MEMORY CONCERNS:302MG/DL, 347MG/DL, 508MG/DL, 523MG/DL, 545MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6770301 ↗
• MalfunctionJun 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT OF E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP. DURING THE CALL ON (B)(6) 2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017 AS A RESULT OF THE METER'S READINGS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM.THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/17/2018 AND OPEN VIAL DATE WAS TWO WEEKS AT TIME OF CALL. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6619817 ↗
• MalfunctionJun 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER COMPLAINT OF E-3 ERROR; TEST STRIP ERROR. E-3 ERROR OCCURRED UPON INSERTION OF TEST STRIP INTO METER PORT. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017, AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2017 PRODUCED RESULT OF E-3 UPON INSERTION OF TEST STRIP INTO METER PORT. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/19/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE CUSTOMER DOES NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM CONTROL TEST. ADVERSE EVENT NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6619472 ↗
• MalfunctionJun 5, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-3 AND SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF A HEADACHE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 186MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2018. THE OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER HAVE A HEADACHE. CUSTOMER THINKS IT'S POSSIBLE BECAUSE OF HER DIABETES. CUSTOMER IS GETTING THE ERROR AS SOON AS THE STRIPS ARE INSERTED INTO THE METER. CUSTOMER WAS PUTTING THE BLOOD ON THE STRIPS FIRST. CUSTOMER JUST PURCHASE THE METER AND STRIPS AND IS TRYING TO USE THEM. AFTER TROUBLESHOOTING, CUSTOMER WAS ABLE TO GET A BLOOD RESULTS 186MG/DL NON- FASTING. NO REPLACEMENT NEEDED.

  Patient problems: Headache

  MAUDE report 6610569 ↗
• MalfunctionMay 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 151 MG/DL. CUSTOMER STATED THAT SHE DROPPED THE METER A FEW TIMES AND THE METER HAS BEEN GIVING HIGH BLOOD RESULTS FOR ABOUT A MONTH. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 109 MG/DL. CUSTOMER STATED SHE ONLY TESTS ONCE A DAY (FASTING). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE MADE AN APPOINTMENT TO SEE THE DOCTOR BECAUSE OF THE HIGH BLOOD RESULTS THE METER WAS GIVING. CUSTOMER STATED THAT SHE WAS TOLD THAT HER STRESS LEVEL WAS HIGH AND THAT MIGHT BE A REASON HER RESULTS WERE HIGH; NO NEW MEDICATION WAS GIVEN. CUSTOMER HAD MADE THE APPOINTMENT BECAUSE OF THE HIGH BLOOD RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6589245 ↗
• MalfunctionMay 15, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CARRY (WIFE) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 268 AND 273 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/17/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER STATES THAT HE DOES NOT HAVE AN EXPECTED RANGE BECAUSE OF THE FACT THAT HIS BLOOD SUGAR IS NOT BEING WELL CONTROLLED. HOWEVER, CUSTOMER BELIEVES THAT THE METER IS READING HIGH AND THE DOCTOR'S EXPECTED RANGE FOR HIM FASTING IS 80-100 MG/DL. CUSTOMER IS CONCERN WITH ALL RESULTS OBTAINED IN METER'S MEMORY. DATE AND TIME ARE NOT SET CORRECTLY IN METER'S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567427 ↗
• MalfunctionMay 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. (B)(6), MOTHER, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 580MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 TO 150MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 341 AND 326MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER CALLED WITH CONCERNS REGARDING THEIR METER READING HIGH COMPARED TO THE HOSPITAL METER. CUSTOMER WAS TAKEN TO THE HOSPITAL FOR REASONS NOT RELATED TO DIABETES OR HIGH BLOOD SUGAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6548749 ↗
• MalfunctionMay 3, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI (NON-FASTING). THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/15/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER STATED THEY WOULD CALL BACK WHEN THEY GOT HOME TO TROUBLESHOOT THE METER. CVS PHARMACY CALLED FOR THIS CUSTOMER WHICH IS SAYING THAT THE METER IS READING HI AND THE CUSTOMER IS NOT HAVING ANY SYMPTOMS, THE PHARMACY WANTED THE CUSTOMER TO COME IN AND DO A BLOOD BUT THE CUSTOMER DECIDED TO CALL US BACK WHEN THEY GET HOME AND TROUBLESHOOT THE METER THEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540348 ↗
• MalfunctionApr 12, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 198 AND 196 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 127 MG/DL AND 125 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/27/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6487205 ↗
• MalfunctionMar 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR "HI" BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF THIRST AND FATIGUE. MEDICAL ATTENTION (VIA PHONE) IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/20/2018 AND OPEN VIAL DATE IS LESS THAN ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER'S CAREGIVER CALLED IN FOR ASSISTANCE WITH AN E-5 ERROR. WHILE TROUBLESHOOTING WITH CAREGIVER I ASKED HOW THE CUSTOMER WAS FEELING. CAREGIVER ASKED CLIENT WHO LIVES IN AN INDEPENDENT LIVING FACILITY IF SHE WAS FEELING OKAY AND SHE STATED THAT SHE WAS. HOWEVER, I SPECIFICALLY ASKED IF THE CLIENT WAS DEMONSTRATING ANY SYMPTOMS FROM A LIST LIKE FREQUENT URINATION, INCREASED THIRST AND FATIGUE AND SHE RESPOND YES. CAREGIVER WAS ADVISED TO SEEK IMMEDIATE MEDICAL ATTENTION FOR THIS CLIENT SINCE SHE DOES LIVE ALONE AND I DID NOT WANT HER TO BE LEFT UNTI

  Patient problems: Fatigue; Polydipsia

  MAUDE report 6382876 ↗
• MalfunctionFeb 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR, VERY HIGH BLOOD GLUCOSE RESULT. THE E-5 ERROR APPEARED AFTER THE BLOOD WAS APPLIED TO THE TEST STRIP. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING THIRSTY. CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION; IT WAS VERIFIED NO MEDICAL ATTENTION WAS REQUIRED AT THAT TIME. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED RESULT OF E-5 (2X). THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE CUSTOMER IS ON INSULIN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Polydipsia

  MAUDE report 6331906 ↗
• MalfunctionFeb 14, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 160, 174 AND 193MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS 1/18/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): RESULT 1: 160MG/DL (B)(6) 2017 4:41PM-FASTING, RESULT 2: 74MG/DL (B)(6) 2017 2:37AM- FASTING, RESULT 3: 174MG/DL (B)(6) 2017 11:24PM-FASTING, RESULT 4: 143MG/DL (B)(6) 2017 9:49PM-FASTING, RESULT 5: 193MG/DL (B)(6) 2017 8:45PM-FASTING. SHE TAKES HER BLOOD RESULTS FASTING. SHE HAS NOT HAD ANY CHANGES IN HER DIET OR EXERCISE. SHE TAKES INSULIN TO MANAGE HER DIABETES. SHE STATED THE NUMBER STARTED TO GET HIGHER 2 WEEKS AGO. SHE IS NOT CONCERNED WITH THE RESULT OF 74MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6330018 ↗
• MalfunctionFeb 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER MEMORY OF 233, 211 AND 159 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS OF HIGH BLOOD GLUCOSE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 249 MG/DL USING TRUEMETRIX AIR METER AND 212 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/26/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6305770 ↗